EMA – Publication of a Concept paper on the revision of the COVID-19 vaccines guidance documents

The EMA issued a Concept paper on the revision of the COVID-19 vaccines guidance documents. During the COVID-19 pandemic, the EMA Emergency Task Force (ETF) issued two guidance documents on regulatory requirements for COVID-19 vaccines. The first, issued in November 2020, covered clinical requirements for COVID-19 vaccine approval, and the second, issued in February 2021, addressed quality, non-clinical, clinical and clinical requirements for SARS-CoV-2 variant vaccines. Since these document...